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Deflazacort

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Deflazacort does in the body

Duchenne muscular dystrophy

From the FDA-approved label: Deflazacort is a corticosteroid prodrug, whose active metabolite, 21-desDFZ, acts through the glucocorticoid receptor to exert anti-inflammatory and immunosuppressive effects. The precise mechanism by which deflazacort exerts its therapeutic effects in patients with DMD is unknown.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · KR5YZ6AE4B · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 56 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 7 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
PainNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer1 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Body weight
weight gain
Pain
postoperative pain

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
1 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Tympanometric resolution

The study did not show it

Who was studied
NCT07721610
How many people
501
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change From Baseline at Week 24 in Nasal Congestion/Obstruction Symptom Severity Score

The study did not show it

Who was studied
NCT02898454
How many people
448
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Forced Vital Capacity

The study did not show it

Who was studied
NCT01603407
How many people
196
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Weight gain

The study did not show it

Who was studied
NCT04227483
How many people
150
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

eGFR (abbreviated MDRD equation)

The study did not show it

Who was studied
NCT01817322
How many people
140
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change From Baseline in the Total Score of Performance of Upper Limb (PUL) 2.0 Version at Week 52

The study did not show it

Who was studied
NCT04371666
How many people
98
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • postoperative pain

Measured

Things only a test, a scale or a device shows.

  • weight gain

Meaningful

Things that change how a life goes, not only a number.

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (5)
  • forced vital capacity
  • pharmacokinetic profile
  • improvement of proteinuria
  • renal dysfunction
  • hypertension

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Deflazacort oral suspension is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Additional pediatric use information is approved for PTC Therapeutics, Inc.'s Emflaza ® (deflazacort) oral suspension. However, due to PTC Therapeutics, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness in pediatric patients below the age of 2 years have not been established.”

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

  • On older people, the label states: “DMD is largely a disease of children and young adults; therefore, there is no geriatric experience with deflazacort oral suspension.”

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.”

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.”

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is required in patients with mild or moderate hepatic impairment [see Clinical Pharmacology ( 12.3 )] .”

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment is required in patients with mild, moderate or severe renal impairment [see Clinical Pharmacology ( 12.3 )] .”

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Sold as tablet, suspension, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Deflazacort appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1108 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • weight increased — 331 reaction mentions
  • fall — 145 reaction mentions
  • nasopharyngitis — 119 reaction mentions
  • abnormal behaviour — 93 reaction mentions
  • influenza — 88 reaction mentions
  • abdominal pain upper — 74 reaction mentions
  • increased appetite — 72 reaction mentions
  • anger — 71 reaction mentions
  • gastroenteritis viral — 58 reaction mentions
  • aggression — 57 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 60 products list this as an active ingredient in the United States drug directory. 60 of them contain it and nothing else.

    FDA National Drug Code directory · 73190-068 · read 2026-08-29

  • They are sold as powder, suspension and tablet, taken oral.

    FDA National Drug Code directory · 73190-068 · read 2026-08-29

  • The regulator's established pharmacologic class for it is corticosteroid hormone receptor agonists [moa] and corticosteroid [epc].

    FDA National Drug Code directory · 73190-068 · read 2026-08-29

  • 16 published labels name it as an active ingredient. 16 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-29

  • Deflazacort Oral Suspension is oral at 3 DOSAGE FORMS AND STRENGTHS Oral Suspension 22.75 mg/mL: White to off-white suspension Oral Suspension: 22.75 mg/mL ( 3 ), recorded as fda label in effect 2026-06-03 in the United States.

    US prescribing information · 881785a5-41b4-4679-a29b-5d77ca51ca60 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Deflazacort studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Deflazacort are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 16 documents were read for this substance.

    RNAWiki source record

  • 16 of them state the same tMax, and they agree.

    RNAWiki source record

  • 16 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
KR5YZ6AE4B
RxNorm concept
1870964

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 13 approved applications cover products containing this substance. The earliest was NDA208685, approved 20170209 to PTC THERAP.

    Drugs@FDA application register · NDA208685 · read 2026-08-29

  • Marketing status on the register: prescription.

    Drugs@FDA application register · NDA208685 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20080416.

    FDA National Drug Code directory · 73190-068 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

6 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • The path through the body — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (11)

What did Deflazacort's largest trial (1200 people) and its longest (8.9 years) measure?


1200 people in Deflazacort's largest registered study, 8.9 years in its longest registered window, measuring The area under the plasma concentration time curve, from time 0 to the last measurable concentration non-zero, for single-state pharmacokinetics on Day 1 of deflazacort and 21-desacetyl-DFZ, the… ClinicalTrials.gov · 2026-09-01

6 phase1, 5 phase3, 2 na or unstated, 2 phase2, 2 phase4; NCT03015974; 2024-12; no ageing endpoint recorded. Last human test completed 2026, NCT07721610.

Interpretation These counts include studies where Deflazacort was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase1
    6
  • phase3
    5
  • na or unstated
    2
  • phase2
    2
  • phase4
    2
  • Last recorded human test NCT07721610
    2026-05-01

recorded 2026-09-01 · last checked 2026-09-04

Deflazacort was tested only in human — what did it show?


human: biomarker (15): the rungs where Deflazacort has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

The area under the plasma concentration time curve, from time 0 to the last measurable concentration non-zero, for single-state pharmacokinetics on Day 1 of… — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT02251600
    biomarker; The area under the plasma concentration time curve, from time 0 to the last measurable concentration non-zero, for single-state pharmacokinetics on Day 1 of deflazacort and 21-desacetyl-DFZ, the active metabolite; 15

recorded 2026-09-01 · last checked 2026-09-04

2 of Deflazacort's trials stopped: safety, futility/efficacy?


safety (1) and futility/efficacy (1): Deflazacort's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Study is no longer necessary given the safety and efficacy of emflaza in this age range has already been established after review of already available data."; 2 of 15 registered studies

Show the evidence

Trial

  • NCT03642145
    withdrawn; "Study is no longer necessary given the safety and efficacy of emflaza in this age range has already been established after review of already available data."
  • NCT03783923
    terminated; "The study was terminated early due to low enrollment and missing efficacy assessment data due to missed visits related to COVID-19."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Deflazacort used Deflazacort 30 MG Oral Tablet — over how long?


Human studies of Deflazacort used "Deflazacort 30 MG Oral Tablet". ClinicalTrials.gov · 2026-09-01

2 recorded entries; human; also "Oral deflazacort 30 mg"

Show the evidence

human

  • NCT04365088
    Deflazacort 30 MG Oral Tablet
  • NCT07721610
    Oral deflazacort 30 mg

recorded 2026-09-01 · last checked 2026-09-04

Could one person measure Deflazacort's effect on forced vital capacity?


Forced vital capacity: measured in Deflazacort's trials.

Interpretation forced vital capacity is the recorded endpoint.

Show the evidence

biomarkers

  • forced vital capacity; 2026-09-01
  • pharmacokinetic profile; 2026-09-01
  • improvement of proteinuria; 2026-09-01
  • renal dysfunction; 2026-09-01
  • hypertension; 2026-09-01
  • weight gain; 2026-09-01
1 more recorded row
  • biomarkers
    postoperative pain; 2026-09-01
  • human trials at or under30
    7
  • Not recorded for this substance
    a recorded half-life
  • smallest human trial
    0; NCT03642145; PHASE3; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of forced vital capacity, hypertension and improvement of proteinuria did Deflazacort's trials measure?


forced vital capacity, hypertension and improvement of proteinuria lead 7 outcome terms across Deflazacort's trials. ClinicalTrials.gov · 2026-09-01

Interpretation renal dysfunction, hypertension, weight gain and postoperative pain follow.

Show the evidence
  • forced vital capacity
    1
  • pharmacokinetic profile
    1
  • improvement of proteinuria
    1
  • renal dysfunction
    1
  • hypertension
    1
  • weight gain
    1
1 more recorded row
  • postoperative pain
    1

recorded 2026-09-01 · last checked 2026-09-04

What will the one ongoing trial of Deflazacort report, and when?


1 registered trial of Deflazacort is open; earliest completion 2025-07. ClinicalTrials.gov · 2026-09-01

Interpretation Weight gain

Show the evidence
  • Trial NCT04227483
    "Deflazacort Vs. Prednisolone in Acute-stage ABPA"; n 150; "Weight gain"; 2025-07

recorded 2026-09-01 · last checked 2026-09-04

Which 6 trials of Deflazacort posted no result?


Posted no result
6 of 6 completed trials
Registrations
NCT00527228, NCT02286609, NCT02286622, NCT02485431, NCT02251600 and NCT02295748
Completion dates
oldest 2008-09; newest 2017-08-24
Show the evidence

Trial

  • NCT00527228
    2008-09
  • NCT02286609
    2015-02
  • NCT02286622
    2015-02
  • NCT02485431
    2015-08
  • NCT02251600
    2015-10
  • NCT02295748
    2017-08-24

At the median, Deflazacort's trials enrolled 30 people — anything larger?


Median enrolment
30
Largest enrolment
1200
Registered trials counted
14

What do 1108 spontaneous reports say about Deflazacort — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Deflazacort appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1108 reaction mentions were counted: weight increased 331; fall 145; nasopharyngitis 119; abnormal behaviour 93. open-targets-adr · CHEMBL1201891 · 2026-06-24

Show the evidence
  • weight increased
    331
  • fall
    145
  • nasopharyngitis
    119
  • abnormal behaviour
    93
  • influenza
    88
  • abdominal pain upper
    74
4 more recorded rows
  • increased appetite
    72
  • anger
    71
  • gastroenteritis viral
    58
  • aggression
    57

recorded 2026-06-24 · last checked 2026-09-04

Deflazacort and CYP3A4, PGP and BCRP: shared by which compounds?


CYP3A4, PGP and BCRP appear in Deflazacort's recorded interaction sentences, 4 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence
  • CYP1A2 pharmacokinetics
    Drug-Metabolizing Enzyme Induction 21-desDFZ and 6β-hydroxy-21-desacetyl deflazacort at clinically relevant concentrations did not significantly induce CYP1A2, 2B6, or 3A4.

CYP3A4

  • pharmacokinetics
    Elimination Metabolism Deflazacort is rapidly converted to the active metabolite 21-desDFZ by esterases after oral administration. 21-desDFZ is further metabolized by CYP3A4 to several other inactive metabolites, including 6β-hydroxy-21-desacetyl deflazacort.
  • pharmacokinetics
    Compared to administration of deflazacort alone, administration of deflazacort following multiple doses of a strong CYP3A4 inducer (rifampicin) resulted in markedly lower C max , AUC last , and AUC inf values of 21-desDFZ.
  • pharmacokinetics
    Drug Interaction Studies In Vivo Assessment of Drug Interactions Compared to administration of deflazacort alone, administration of deflazacort following multiple doses of a strong CYP3A4 and Pgp inhibitor (clarithromycin) resulted in markedly higher C max , AUC last , and AUC inf values of 21-desDFZ.

recorded 2026-08-30 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201891
PubChem CID
189821
CAS number
14484-47-0
RxCUI
22396
InChIKey
FBHSPRKOSMHSIF-GRMWVWQJSA-N
Also called
Azacortinol, 11 β, 21-dihydroxy-2'-methyl-5' β-H-pregna-1,4-dieno[17,16d]oxazole-3,20-dione-21-acetate, 5′H-Pregna-1,4-dieno[17,16-d]oxazole-3,20-dione, 21-(acetyloxy)-11-hydroxy-2′-methyl-, (11β,16β)-, Deflazacort [INN], Deflazacort [MART.], Deflazacort [MI], Deflazacort [ORANGE BOOK], Deflazacort [USAN], Deflazacort [USP-RS], Deflazacort [WHO-DD]
Trade name
Calcort, Emflaza, Zamene, Jaythari, Kymbee, Pyquvi
Development code
DL-458IT, L-5458, MDL 458, MDL458
Salt form
Deflazacort Oral Suspension, Jaythari Oral Suspension, DEFLAZACORT ORAL, Emflaza / Jaythari / Kymbee / Deflazacort Oral Suspension / Pyquvi / Jaythari Oral Suspension
Sources (9)

Sources

3 more sources
  • openfda-label 2fac1332-0247-1047-e063-6294a90a557f ·
  • openfda-label+europepmc K1:KR5YZ6AE4B ·
  • national registers US ·

ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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